Application of Quality Control Principles to Herbal Drugs.

Abstract

Quality is conformance to requirement and meeting stated as well as implied needs of customer. The word quality is derived from Latin ‘qualis’ means ‘of what kind’ and encompasses composition and properties of object. Quality is of paramount importance when it is specifically related with drugs. And when it comes to herbal drugs, because of several reasons is a herculean task. The quality of pharmaceuticals has been a concern of the World Health Organization (WHO) since its inception. The setting of global standards is requested in Article 2 of the WHO Constitution, which cites as one of the Organization’s functions that it should “develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products”. The World Health Assembly - in resolutions WHA31.33 (1978), WHA40.33 (1987) and WHA42.43 (1989) - has emphasized the need to ensure the quality of medicinal plant products by using modern control techniques and applying suitable standards. This manual describes a series of tests for assessing the quality of medicinal plant materials. The tests are designed primarily for use in national drug quality control laboratories in developing countries, and complement those described in ‘The international pharmacopoeia’ which provides quality specifications only for the few plant materials that are included in the WHO ‘Model List of Essential Drugs'. In this review, we have addressed some important issues related to quality of botanicals and discussed possible application of total quality management for herbal drugs. Keywords: WHO, Herbal Drugs, Quality Control.